ECTU University Hospital Wuerzburg

The Early Clinical Trial Unit (ECTU) was successfully implemented at Wuerzburg University in September 2007 and is part of the Comprehensive Cancer Center Mainfranken (CCMF). The ECTU is a highly specialized, interdisciplinary clinical trial unit for experimental tumor therapy where phase I, I/II and phase II trials with novel compounds, exclusively in oncology can be rapidly carried out. Early, safe and convenient access to novel compounds can now be provided for late-stage oncology patients in a setting led by highly experienced physicians, all operating according to the latest good clinical practice (GCP) standards. The ECTU enables enhanced trial activities in the field of solid tumors and innovative treatment strategies including a broad variety of immunotherapies and inhibitors of oncogenic signaling pathways. Since 2007, the ECTU has received funding as therapeutic unit with clearly assigned staff and infrastructure from the faculty (IZKF grants 2007-2013, ongoing continued financing through the Medical Faculty since 2013).

To guarantee our patients’ safety and ensure high quality standards in early-stage clinical trials for the treatment of cancer patients we offer:

• An infrastructure corresponding to the study requirements for the implementation of phase I therapy concepts (staff, premises, intensive care options)
• A patient-oriented organization
• Interdisciplinary cooperation between the specialized disciplines involved in oncological care
• Close cooperation between all staff at all CCC MF institutions
• A cross-sectoral range of services and networking with other service providers
• Close and binding cooperation with other facilities involved in the care of cancer patients, including specialized hematologic clinics, oncogenic medical practices, and resident medical colleagues
• Years of experience in the implementation of early clinical trials and international randomized studies

The ECTU is located in the Hematology and Internal Oncology department of the Second Medizinische Klinik, in order to meet the requirements of emergency care and intensive care treatment in the case of serious adverse drug reactions. The following premises have been assigned to the ECTU:

• 4 beds for inpatient treatment
• 4 outpatient treatment rooms
• Specimen laboratory, refrigerated centrifuge
• A conference room with 2 stations
• One cold room for the storage of trial drugs
• Specimen storage (-20°and -80° freezer)
• Connection to the central biobank
• Facilities for biomarker und PK sampling

• Intensive care in interdisciplinary critical care stations at the clinic, emergency outpatient therapy available at all times, as well as for stationary in-patients
• An experienced pharmacy with clinical trial experience and GCP-trained staff, expertise in GCP-conform IMP handling
• Cooperation with the Clinic for Nuclear Medicine (PET-CT, skeletal scintigraphy, bone density measurements, MUGA Scan etc.), as well as the Institute of Diagnostic Radiology with state-of-the-art imaging technology
• Close cooperation with the regional clinical trial network of the CCC Mainfranken